JP2024503690A - Gastrojejunal tube device and usage method - Google Patents

Abstract

A gastrojejunal (GJ) tube device and a method of using a gastrojejunal (GJ) tube device, the GJ tube device having a plurality of tubes forming a lumen within the device, and a guide tube having a closed end. It is exposed by cutting a portion of the GJ tube device and the insertion of a guide wire therethrough, for example, to assist in the placement of a new GJ tube when the existing tube becomes clogged or blocked. enable.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63/140,060, filed on January 21, 2021, entitled "GASTROJEJUNAL TUBE APPARATUS AND METHOD OF USE." , the entire disclosure of which is hereby expressly incorporated by reference.

The present disclosure relates generally to gastrostomy feeding tube devices, and more particularly to gastrostomy feeding tube devices configured to allow simultaneous delivery of materials above and below the pyloric valve/pylorus of the gastrointestinal tract.

Gastrojejunal (GJ) feeding tube device 20 is a tube that is inserted through an incision in abdomen 24 into stomach 22 and the jejunal portion of small intestine 38 . GJ tubes are used in a variety of situations, usually in patients with impaired gastric motility, patients at high risk of respiratory esophageal reflux, and patients with pancreatitis, where direct gastric feeding alone is undesirable or dangerous. or in patients with some other conditions. GJ tube device 20 allows nutrients, hydrates, other fluids, and medications to be delivered directly to a location below pyloric valve 36 in jejunum 38 past duodenum 48 .

A typical GJ tube device 20 includes a first end 26 and a second end 40, as shown in FIG. First end 26 includes a plurality of access ports 28 , 30 , 32 that allow access to internal tubes that extend in parallel directions through the body of device 20 . Each tube defines a lumen. The terms "tube" and "lumen" are sometimes used interchangeably herein with reference to a fluid passageway (lumen) and a physical structure that forms a fluid passageway (tube). No limitations to structure are intended. When a "tube" is referred to, the element will be understood by a definition defining at least one lumen. Any tube referred to herein may be an individual tubular element, one of several individual tubular elements attached together, or a single tube, each inner wall defining a fluid passageway. It can be one of a plurality of integral interior walls of the structure. Thus, a device with three tubes defines three lumens and can be, for example, one single extruded elongated part or three attached elongated parts. One access port 28 and associated tube are connected to a balloon portion 34 that can be inflated at least temporarily once the GJ device is positioned to prevent accidental withdrawal or movement of the device. can. The second access port 30 and associated tube 44 provide access to an opening 52 located within the stomach, through which nutrients, hydrates, other fluids, and/or fluids can be delivered directly to the stomach. Allows for the introduction of drugs. The third access port 32 and associated tube 42 provides access to an opening 50 located within the jejunum to introduce nutrients, hydrates, other fluids, and/or medications directly into the jejunum. make it possible. The GJ device 20 may also include a disc portion 46 or other external positioning/retention element that rests on the skin and can prevent extreme insertion of the device into the stoma 47, for example.

The procedure for placing a GJ tube device is typically performed by a clinician in a radiology room so that ultrasound, x-ray, and/or other imaging techniques can be used to assist in accurate placement of the device. Although care is typically taken to keep GJ tube devices clean and in good order, it is not uncommon for at least one of the tubes to become clogged. A variety of different techniques have been developed to attempt to clear blockages once they occur, such as those shown in US patent application Ser. No. 13/679,160 to Honig. Although such techniques have varying success rates, a certain percentage of tubes usually fail to be completely or at least substantially unclogged. The clogged tube must be removed and a new one placed typically uses the same time and resources to accurately guide and place the new GJ tube device as the initial placement procedure. There is a need for devices and procedures that reduce the time and effort required to place subsequent GJ tube devices in a patient.

In one embodiment, a method of treating a patient includes establishing access from a location outside the patient's body to a normally closed collection lumen extending parallel to a supply lumen in a gastrojejunal (GJ) tube device; and advancing a guidewire through the lumen. The method further includes withdrawing the GJ tube device from the patient's body while leaving the guidewire in place. The method involves advancing the new GJ tube device over the guidewire to a treatment location where the gastric and jejunal feed ports of the new GJ tube device are above and below the pylorus in the patient's gastrointestinal tract, respectively; Still further including removing.

In another aspect, a gastrojejunal (GJ) tube device includes a device body having an outer wall, a first proximal end, and a second distal end. The outer wall further includes an inflatable balloon portion and optionally at least one cutting mark. The plurality of tubes run generally parallel to each other within the device body and define a first tube having an opening at the proximal end of the device body and an opening at the inflatable balloon portion, and an opening at the proximal end and a gastric feeding port. a second tube having an opening between the proximal end and the distal end; a third tube having an opening at the proximal end and an opening at the distal end forming a jejunal supply port; and a guide tube having a closed end distal to the gastric feeding port and terminating at a location distal to the gastric feeding port. Cutting the device body, eg, at at least one cutting mark, creates an opening for the guide tube.

In yet another aspect, the above-described method of replacing a GJ tube device is provided such that the target area or location that may be indicated by the at least one cutting mark is located outside the abdominal wall (if the cutting mark is not already outside the abdominal wall), e.g. withdrawing a portion of the existing GJ tube device from the patient until it is present, cutting the existing GJ tube device to create an opening in the guide tube, and inserting a guidewire through the opening in the guide tube; Withdraw the existing GJ tube device, leaving the guide wire in place in the patient, and insert the new GJ tube device over the guide wire until the distal end of the new GJ tube is past the pyloric valve and into the small intestine. This is accomplished by placing a new GJ tube device into the patient by threading it over the patient, withdrawing the guidewire from the device, and securing the new GJ tube device to the patient.

In yet another aspect, a gastrojejunal (GJ) tube device includes a device body having an outer wall, a first proximal end, and a second distal end, and an inflatable balloon portion. The first tube of the device body defines an inflation fluid lumen extending between the proximal end of the device body and the inflatable balloon portion. The second tube of the device body defines a gastric feeding lumen beginning at the proximal end of the device body and terminating in a gastric feeding port formed between the proximal and distal ends of the device body. The third tube of the device body defines a jejunum supply lumen that begins at the proximal end of the device body and terminates in a jejunum supply port formed at the distal end of the device body. The guide tube of the device body defines a collection lumen that begins at the closed end and ends at a location distal to the gastric feeding port.

In yet another aspect, a medical device includes a device body having an outer wall, a first proximal end, and a second distal end. The first tube of the device body defines a lumen having a first opening at the proximal end of the device body and a second opening at the distal end of the device body. The second tube of the device body has an open first end at the proximal end of the device body and a closed second end disposed between the proximal end of the device body and the distal end of the device body. forming a lumen having The third tube of the device body has a closed first end disposed between the device body proximal end and the device body distal end, and an open second end portion at the device body distal end. forming a lumen having The medical device may further include at least one cutting mark on the device body that may be positioned such that cutting the device at the cutting mark creates a second open end of the third tube.

In a further aspect, a GJ tube replacement kit includes a replacement GJ tube having one or more of the features disclosed above, as well as a guide wire, fixation, and the like required for removal and replacement of existing GJ tube devices. including one or more other devices, such as a clip, etc.

FIG. 1 is an exemplary diagram showing the placement of a gastrojejunal (GJ) tube device. FIG. 2 is a top view of a GJ tube device according to one embodiment. 3 is a plan view of a portion of the apparatus shown in FIG. 2; FIG. FIG. 2 is a top view of a GJ tube device according to one embodiment. FIG. 2 is a top view of a GJ tube device according to one embodiment. FIG. 2 is a cross-sectional view of a GJ tube device body according to one embodiment. FIG. 2 is a cross-sectional view of a GJ tube device body according to one embodiment. FIG. 2 is a cross-sectional view of a GJ tube device body according to one embodiment. FIG. 2 is a cross-sectional view of a GJ tube device body according to one embodiment. FIG. 3 is an exemplary diagram illustrating replacement of a GJ tube device according to one embodiment. FIG. 3 is an exemplary diagram illustrating replacement of a GJ tube device according to one embodiment. FIG. 3 is an exemplary diagram illustrating replacement of a GJ tube device according to one embodiment. FIG. 3 is a cross-sectional view of the tip of a GJ tube device, according to one embodiment. FIG. 2 is a top view of a GJ tube device according to one embodiment. FIG. 15 is a perspective view of the distal end of the GJ tube device of FIG. 14; FIG. 3 is a side view of a fixation clamp according to one embodiment. FIG. 17 is a perspective view of the fixation clamp of FIG. 16; FIG. 2 is an exemplary diagram illustrating replacement of a GJ tube apparatus according to one embodiment. FIG. 3 is an exemplary diagram illustrating replacement of a GJ tube device according to one embodiment. FIG. 2 is a top view of a GJ tube device according to one embodiment. FIG. 2 is a cross-sectional view of a GJ tube device according to one embodiment.

Referring to the drawings, a medical device according to some embodiments is shown. This specification is understood to refer generally to all embodiments, unless otherwise indicated or clear from the context. Discussion herein of features or functionality of any one embodiment figuratively refers to features or functionality of any other embodiment, unless otherwise indicated or clear from context. It should be understood that References to "first," "second," "third," and similar descriptions are used solely for convenience and to avoid any specific identification, order, or order of the described elements. or the array is not considered necessary.

2-3 illustrate a gastrojejunal (GJ) tube device 100 according to one embodiment of the present disclosure. In this example, tube device 100 includes a first proximal end portion 110 or “hub” and a second distal end portion 112. The first end portion 110 includes a first access port 104 associated with a first tube 124 forming an inflation fluid lumen and a second access port 104 associated with a second tube 126 forming a first supply lumen. It includes an access port 106 and a third access port 108 associated with a third tube 128 forming a second supply lumen. Access ports 104, 106, 108 may include closure devices or covers, such as removable caps. Tubes 124, 126, 128 run generally parallel to each other through elongated device body 102. The first access port 104 and tube 124 are operatively connected to the balloon portion 118 to allow for the introduction and removal of an inflation fluid, such as saline solution, contrast agent, water, or air, into the balloon portion 118 as desired. Make it. The second access port 106 and tube 126 are operatively connected to the opening 116, which allows access to the stomach once the device 100 is placed within the patient. Third access port 108 and tube 128 are operatively connected to opening 114, which allows access to the jejunum once device 100 is placed within a patient. The device 100 may further include at least one indicium 120 (cutting indicator). Indicia 120 may be one or more marks formed in the material of device 100, such as a line or ridge, or a series of lines/ridges, or one or more bulges, to name a few. good. Indicia 120 may also include colored or other indelible markings or other visible features, surface texture features, or even other indicia that provide visual and/or tactile features. In the embodiment shown, indicia are shown both proximally and distally of balloon portion 118. In some cases, only indicia distal to balloon portion 118 or only indicia proximal to balloon portion 118 are used.

Indicia 120 is located in a transition region 122 of device body 102 where a fourth tube 130 that forms a normally closed collection lumen begins and runs generally parallel to tubes 124, 126, 128 through device body 102. Indicia 120 cuts through device body 102 to remove or partially remove first end 110 from device 100, thereby allowing access to fourth tube 130 and associated collection lumen. Creating a fourth access port or point 132 marks where a new access opening to tube 130 may be established. The fourth tube 130 typically provides access to the small intestine at some point distal to the gastric feeding port and past the pyloric valve/pylorus when the device 100 is placed within the patient. Ends with 4 openings. The opening in the fourth tube 130 that forms the collection lumen may include a valve, a membrane that can be pierced through a guidewire, or a valve that may be removed, enlarged, or removed when the collection lumen is used as discussed herein. It can include a normally closed opening formed by another plug or closure that can be opened. In one embodiment, the distal opening of the collection lumen (the fourth opening of the fourth tube 130) is located at the distal distal tip of the device 100. In other examples, it may be positioned proximal to the distal tip, proximal to the jejunal feed port, and formed in the nature of a side port. In yet other examples, a distal normally closed opening may be located at the distal end tip of the device 100, as discussed below in connection with FIG. It may even be located distal to the mouth.

Embodiments are also contemplated in which the guide tube forming the collection lumen is a distal portion of tube 126 forming the gastric feeding lumen. As will be apparent to those skilled in the art, a GJ tube can be formed with a lumen that extends the entire longitudinal length of the device, but does not allow feeding into the gastric feeding port proximal to the unavailable distal portion. occluded or closed at the distal portion to supply fluid or the like. According to the present disclosure, the retrieval lumen may be an extension or continuation of the gastric feeding lumen that is accessed or opened to receive a guidewire for device exchange. Those skilled in the art will also be familiar with the conventional function of gastric feeding tubes and the conventional structures for plugging or occluding the distal portion of gastric feeding tubes. According to the present disclosure, the normally occluded or occluded portion may be removed by removing and cutting the GJ tube device at the cutting marks described herein, but up to the distal tip of the GJ tube device. Possibility of access by drilling a hole with a guide wire through an occluded, occluded, or valved portion to establish a recovery lumen that extends to a complete or near location. There is also. In such applications, users may employ a relatively hard-tipped guidewire to open the collection lumen and then replace that guidewire with a softer-tipped guidewire, but other In this example, the same guidewire may be used. As still further discussed herein, the collection lumen and associated tube may serve to reinforce the GJ tube device. Embodiments are contemplated in which the normally closed or occluded portion of the gastric feeding lumen distal to the gastric feeding port has a desired stiffness to prevent kinking as discussed herein. The entire gastric feeding lumen, including the proximal portion used for the gastrostomy and the normally closed distal portion used as the collection lumen, has a greater stiffness than other parts of the GJ tube device. May have.

When the device 100 becomes clogged due to material stuck to one or both of the gastric and jejunal feeding lumens and requires replacement, a guidewire is inserted through the length of the tube 130 and the clogged GJ tube device is removed. The new GJ device may then be deployed by following the length of the guidewire to maintain the proper deployment path. The guidewire may then be removed and a new GJ tube device secured as desired. The fourth tube 130 provides clear access past any blockages in the pyloric valve/pylorus and jejunal feeding lumen and assists in placement of a new GJ tube device over the guidewire if necessary. By surrounding the opening 132 to the tube 130 (the closed blind end of the tube 130), the tube remains unintentionally unused, unobstructed, and sterile, and does not provide an avenue for patient infection. Or, it is guaranteed that it does not exhibit any other problems. With traditional GJ tubes, only one of the tubes (the one that accesses the jejunum) usually provides access to a point past the pyloric valve/pylorus, and that tube is often clogged, possibly blocked. As such, it cannot be used to insert a guide wire past a blockage in the tube when used to provide nutrients, etc. to the jejunum.

FIG. 4 shows a gastrojejunal (GJ) tube device 140 according to another embodiment. In this example, the GJ tube device includes a first end 142 and a second end (not shown). The first end 142 has a first access port 144 associated with the first tube, a second access port 146 associated with the second tube, and a third access port associated with the third tube. 148. GJ tube apparatus 140 defines a collection lumen and has a fourth access associated with a fourth tube 150 disposed along GJ tube body 156 between first end 142 and second end. Further includes a port 152. Fourth access port 152 includes a sealing portion 154 to prevent entry of substances into tube 150. Seal portion 154 may be a removable/replaceable device such as a cap, lid, or plug, or a hermetic closure that must be cut to allow access to opening 152 and tube 150. It may be. Optionally, one or more indicia 158 may be included on tube body 156 to indicate where GJ tube apparatus 140 may be cut to allow access to tube 150.

FIG. 5 shows a gastrojejunal (GJ) tube device 160 according to another embodiment. In this example, GJ tube device 160 includes a first end 162 and a second end (not shown). The first end 162 has a first access port 164 associated with the first tube, a second access port 166 associated with the second tube, and a third access port associated with the third tube. 168. GJ tube apparatus 160 further includes a fourth access port 170 disposed at first end 162 and associated with a fourth tube 172 defining a collection lumen. Fourth access port 170 may include a sealing portion 174 to prevent entry of substances into tube 172. Seal portion 174 may be a removable/replaceable device such as a cap, lid, or plug, or a seal that must be cut to allow access to access port 170 and tube 172. It may be a closure. Optionally, one or more markings 176 may be included on the tube body to indicate where GJ tube apparatus 160 may be cut to allow access to tube 172.

Referring now to FIG. 13, a GJ tube device 300 is shown having a distal tip 310. The device 300 may be any of the embodiments contemplated herein or may be combined with any of the embodiments contemplated herein and includes a collection formed by a guide tube 320. Includes lumen 322. A jejunal feeding lumen 328 extends through device 300. A radiopaque marker 330 is attached to the tip 310 in the embodiment shown. A guidewire is shown at 326 as visible at the distal opening of the collection lumen 322, immediately proximal to a diaphragm 324 or another suitable closure, such as a valve. As discussed herein, a variety of different closure techniques may be used for the distal opening of the retrieval lumen, such that the retrieval lumen is typically closed until the time it is opened for use. can. It will be appreciated that the collection lumen 322 may be normally closed at both its proximal and distal ends. The guide tube 320 may be associated with or otherwise attached to a reinforcing element, such as an embedded coil, which may be formed from a reinforcing material as described herein. The guide tube 322 may be configured to provide a desired enhanced stiffness to the portion of the device 300 that the guide tube 322 extends through. Guide tube 320 may run the entire length of device 300 and is normally closed and can be opened by cutting or removing the closure at the proximal end, although in some embodiments herein There may also be only a partial length of device 300, as discussed in connection with . Device 300 also includes one or more weights 322 embedded in the material of tip 310, which weights 332 assist in advancing tip 310 and device 300 through the patient's body, such as past the pylorus. The weight 322 may be made of metal, for example.

6-9 illustrate cross-sectional views of gastrojejunal (GJ) tube device bodies according to some embodiments. These examples are provided for illustrative purposes only, and the exact size, shape, and configuration of the tubes in different embodiments may vary. Typically, the tube used to provide access to the stomach and jejunum will be larger than the tube and guidewire placement path or retrieval lumen that provides access to the balloon portion. The exact size, shape, and configuration of individual tubes may vary according to the requirements and design of the particular GJ tube device. GJ tube walls may be made from a variety of materials such as elastomeric polyurethanes, polyacrylates, polyolefins, polyamides including nylons, polyesters, fluoropolymers, silicones, polyphosphazenes, perfluoroelastomers, fluoroelastomers, and copolymers, such as Derivatives, mixtures, and alloys of other polymers may also be used. Additionally, reinforcing materials such as metals and/or composites may be included in all or a portion of the GJ tube wall, as desired. The fourth tube forming the collection lumen may include polyimide, for example.

In some embodiments, other parts or the entire GJ device other than the fourth tube forming the collection lumen may be formed from the first material, and the fourth tube is made of the first material. may be formed from a different second material. Some tubes of GJ tube devices according to the present disclosure may be coextruded. In some embodiments, the fourth tube is inserted into a lumen formed in the GJ tube device body and attached, for example, by adhesive, melting, frictional retention, or any other suitable method. It can be embedded in it. In yet other embodiments, the fourth (rescue) lumen may be formed with both ends open, with one end, the proximal end, then being closed prior to placing the lumen within the GJ tube device. / sealed.

In a first example shown in FIG. 6, a GJ tube device 180 includes an outer wall 182 that surrounds and defines an outer periphery of a plurality of tubes. The tubes include a first tube 188 , a second tube 190 , a third tube 186 , and a fourth tube 192 . First tube 188 and second tube 192 are separated by septum 184. Third tube 186 and fourth tube 192 in this example are separated from first tube 188 and second tube 190 by thickened portions 194, 196 of outer wall 182, respectively.

In the example shown in FIG. 7, GJ tube device 200 includes an outer wall 202 that surrounds and defines the outer periphery of a plurality of tubes. The tubes include a first tube 210, a second tube 212, a third tube 206, and a fourth tube 208. First tube 210 and second tube 212 are separated by septum 204. Third tube 206 and fourth tube 208 in this example are separated from first tube 210 and second tube 212 by thickened portion 214 of outer wall 202 .

In a third example shown in FIG. 8, a GJ tube device 220 includes an outer wall 222 that surrounds and defines an outer periphery of a plurality of tubes. The tubes include a first tube 224, a second tube 226, a third tube 230, and a fourth tube 232. First tube 224 and second tube 226 are separated by a septum 228. Third tube 230 and fourth tube 232 in this example are separated from first tube 224 and second tube 226 by thickened portions 234 , 236 of outer wall 222 . In this particular example, third tube 230 and fourth tube 232 are shown to have elliptical cross-sections. Additionally, third tube 230 is defined by a wall 238 that includes one or more reinforcing materials as previously discussed. The walls 238 of the third tube 230 in this example generally serve to resist twisting of the device during and after deployment, particularly as it advances past the pyloric valve/pylorus during deployment, as well as The wall 222 of the tube 220 prevents pinching and possible collapse of one or more of the other tubes. The material from which wall 238 is made, such as polyimide, may have anti-torsional stiffness compared to the stiffness of other tube walls. In this example, wall 238 and third tube 230 form a collection lumen with a closed blind end outside the plane of the page of FIG. Tube 230 is cut to form a new opening in tube 230 that feeds the guidewire through device 220, as described herein.

In a fourth example shown in FIG. 9, a GJ tube device 250 includes an outer wall 252 that surrounds and defines an outer periphery of a plurality of tubes. The tubes include a first tube 256 , a second tube 254 , a third tube 260 , and a fourth tube 262 . First tube 256 and second tube 254 are separated by a septum 258. In this particular example, first tube 256 is larger than second tube 254. Third tube 260 and fourth tube 262 in this example are separated from first tube 256 by thickened portion 264 of outer wall 252 . In this particular example, third tube 260 and fourth tube 262 are shown to have elliptical cross-sections. Additionally, portions of outer wall 252 include one or more reinforcing materials 266 as previously discussed. Portions of wall 252 in this example include integral reinforcements that serve to prevent twisting of the device during and after deployment, as well as prevent pinching and possible collapse of one or more of the tubes of the device. May include. In other examples, all or only selected portions of the outer wall may include reinforcing material to prevent twisting along the entire length of the GJ tube device or only in selected portions of the device.

Various applications of the anti-torsion reinforcement properties of integral reinforcement components can be observed in the field. The enhanced reinforcement can help maintain tube shape and prevent kinking after the GJ tube device is placed and secured in the patient's precise location and the guidewire is removed. During the normal physiological process of gastrointestinal peristalsis, movement of a patient's gastrointestinal tract can sometimes cause or lead to potential obstruction and dysfunction. Additional stiffness at selected locations of the GJ tube according to the present disclosure, including the distal portion within the jejunum, can assist in maintaining the desired position, potentially extending the usable time of the device. Another cause of premature GJ tube failure may be posterior migration of the GJ tube due to retraction and sometimes coiling of the portion of the GJ tube intended for positioning in the jejunum into the patient's stomach. For example, changes in the patient's body can be associated with different orientations of the GJ tube, and changes in the GJ tube angle of incidence at the point of entry can be linked to changes in the physician's choice of performing the procedure, unavoidable interprocedural changes, to name a few. This can occur based on changes in the gastrointestinal tract, the position of the pylorus and related gastric access, and the overall shape of the stomach. Physiological forces such as peristalsis and duodenogastric reflux (associated with GI motility problems, nausea, and vomiting) may contribute to this phenomenon. The additional stiffness described herein includes relatively more rigid material types or inserted or implanted metal coil components in critical regions associated with critical anatomical locations. It can help suppress anatomical variations, placement variability, and physiological processes that can cause undesirable transitions during the intended service life of a GJ tube device.

In another example shown in FIG. 14, GJ tube device 360 includes a first proximal end portion 364 and a second distal end portion 382. Proximal end portion 364 includes a plurality of access ports 366, 368, 370, each of which has a separate lumen (not shown) that allows for the introduction of nutrients, medications, fluids for hydration or balloon inflation, etc. ) is associated with. In other examples, more or fewer access ports are provided. Access ports 366, 368, 370 may include closure devices or covers, such as removable caps. The lumens run generally parallel to each other through the elongated device body 372. One of the access ports and an associated lumen are operatively connected to balloon portion 376 to allow for the introduction and removal of an inflation fluid, such as saline solution, contrast agent, water, or air, from balloon portion 376 as desired. Make it. Disk portion 374 is connected to proximal end 364 such that when the device is placed within a patient and the balloon is inflated, the device is secured in place on the abdominal wall between the balloon and disk portion 374. It is disposed on the device body 372 between the balloon portion 376 and the balloon portion 376 . In this particular example, one of the remaining access ports is associated with a lumen that allows access to the stomach, and another access port and associated lumen are connected to the jejunum once device 360 is placed within the patient. operably connected to an opening allowing access to the opening.

GJ tube device 360 further includes a securing portion 380 disposed about device body 372 at a point between distal end 382 and proximal end 364 . Fixed portion 380 may be made from the same or different material as device body 372. The securing portion 380 may be formed as part of the manufacturing process of the device body 372, or it may be formed separately and then formed (e.g., using a bonding agent, sonic welding, or other suitable fusing method). ) may be later attached and fixed to the device main body 372. Optionally, fixed portion 380 may be generally colored to make it easier to distinguish from device body 372. The fixed portion 380 may be textured to make it easier to identify by grasping and/or touching, and may include indicia indicating cut lines or zones, or the cut indicia may include markings that indicate cut lines or zones, as discussed further herein. , may be placed near, e.g., proximate, the fixation portion 380 to guide the clinician to the appropriate position to create new access to the collection lumen.

A fourth lumen comprising a retrieval or rescue lumen 384 begins at a point between the proximal end 364 and the distal end 382 of the GJ tube device 360 and at the distal end 382 or the distal end 382 of the GJ tube device 360. It runs generally parallel to the other lumens before terminating at a nearby distal end 386. In this particular example, rescue lumen 384 begins at proximal end 378 with a sealed or blind end 362 disposed between fixed portion 380 and proximal end 364 of GJ tube device 360. In other examples, the rescue lumen may begin with a sealed end portion disposed at several points surrounded by a fixed portion. The precise positioning of the proximal end of the rescue lumen according to the disclosed invention and its length relative to the overall length of the GJ tube device body may vary depending on the particular application. In one example, the rescue lumen is at least 50% to 66% of the total length of the GJ tube device body. In another example, in so-called "low profile" GJ tube devices, such as those used in birth situations, the rescue lumen may comprise up to 80% of the total length of the GJ tube device body.

The rescue lumen typically terminates in an opening that provides access to the small intestine at some point distal to the gastric feed port and past the pyloric valve/pylorus when device 360 is placed within the patient. The rescue lumen opening may include a valve, a membrane that can be pierced through a guidewire, or other plug that can be removed, enlarged, or opened when the recovery lumen is used as discussed herein. It can include a normally closed opening formed by a closure. In one embodiment, the distal opening of the collection lumen is located at the distal distal tip of the GJ tube device. In other examples, it may be positioned proximal to the distal tip, proximal to the jejunal feed port, and formed in the nature of a side port. In yet other examples, a distal normally closed opening may be located at the distal end tip of the GJ tube device, as discussed above in connection with FIG. 13, and in some cases, It may even be located distal to the jejunal feed opening.

One example of a distal end of a rescue lumen is shown in more detail in FIG. 15. In this particular example, the distal end 382 of the GJ tube device 360 includes a lumen tip 388 having a first opening 390 and a second opening 392 separated by a partition 394. Partition 394 is positioned and configured to prevent material passing through the lumen of device body 372 from collecting and accumulating within lumen tip 388 . Such build-up may create an obstruction that prevents the GJ tube device 360 and/or valve assembly 396 of the rescue lumen 384 from functioning properly. Optionally, lumen tip 388 is made from a radiopaque material to increase visibility during placement of GJ tube device 360. A distal end 386 of rescue lumen 384 is disposed within the lumen tip and is provided with a concave valve assembly 396 . Valve assembly 396 acts as a check valve to prevent substances (food, medications, etc.) passing through other lumens of GJ tube device 360 from entering rescue lumen 384 and potentially clogging the proximal end. Guide wire advancing through rescue lumen 384 from 378 toward distal end 386 opens valve assembly 396 to allow proper placement of the wire during the GJ tube assembly exchange procedure.

16-17 illustrate an example of a securing clip 400 for use with a GJ tube assembly such as that shown in FIG. 14. In this particular example, the securing clip 400 includes a first portion 414 or jaws having a first securing feature 402 and a clamping portion 408 and a second portion 414 or jaws having a second securing feature 404 and a clamping portion 410. 414 or jaws. First portion 416 and second portion 414 are operably connected at flexible hinge 406 . Block 411 may be within hinge 406 to prevent inadvertent placement of the tube near hinge 406. First portion 416 and second portion 414 may further include an associated gripping portion 412 to allow for easier gripping and use. The hinge 406 allows the first locking feature 402 and the second locking feature 404 to interact to close the clip 400 when the first portion 416 and the second portion 414 are biased toward each other. Configured to hook, snap, lock, or otherwise secure in position. First locking feature 402 and second locking feature 404 are optionally configured to be non-releasable once secured in the closed/latched position. The first clamping portion 408 and the second clamping portion 410 are such that when the securing clip 400 is in the closed/locked position, the clamping portions 408, 410 are closer to the device body 372 of the GJ tube device 360 as shown in FIG. The diameter is also slightly smaller, but in some cases it is sized and configured to form an opening of equal diameter. That is, when the device body 372 is disposed within the clamping portions 408 , 410 of the closing/securing clip 400 , the clamping portions 408 , 410 have sufficient tension to prevent movement of the clip 400 relative to the device body 372 . Pressure is applied on the device body 372, but insufficient pressure to collapse or close the lumen within the device body 372. In other examples, the first clamping portion 408 and the second clamping portion 410 are arranged such that when the securing clip 400 is in the closed/locked position, the clamping portions 408, 410 are connected to the GJ tube apparatus 360 as shown in FIG. is sized and configured to form an aperture that is slightly smaller in diameter than the fixed portion 380 of the. That is, when the device body 372 is disposed within the clamping portions 408, 410 of the closing/locking clip 400, the clamping portions 408, 410 prevent the locking clip from sliding over or past the locking portion 380. 380, thereby preventing the GJ tube from returning to the opening in the abdominal wall.

Optionally, the clamping portions 408, 410 may include a surface skin or substance (such as an adhesive, abrasive, etc.) to enhance the grip between the clamping portions 408, 410 and the securing portion 380. The use of a fixation clip 400 as described in this example in a replacement procedure for a GJ tube apparatus 360 as shown in FIG. 14 is described in further detail below with respect to FIGS. 18-19. The GJ tube assembly as described herein is packaged in a suitable sterile package along with the associated fixation clip(s), guidewire(s), and other items used during the exchange procedure. It is intended that it may be packaged. Such packages ensure that all necessary or desired materials are present and that such materials are accurately sized and configured for use together.

Referring now to FIG. 20, a GJ tube device 660 is shown having similarities with other embodiments discussed herein, but with certain differences. GJ tube device 660 is configured as a multi-lumen catheter including a hub at proximal end 664 and a distal end 686 including distal tip 687. Although not specifically shown, the jejunal feeding lumen extends completely through the GJ tube device 660. A balloon inflation lumen extends to a balloon (not shown). It will be appreciated that such a balloon may be positioned at a location distal to the disk 674, which is generally equivalent to similar structures discussed elsewhere herein. Gastric feeding lumen 670 extends to any suitable number of gastric feeding ports 661 configured as side ports of GJ tube device 660. A plug or backfill material 678 is within gastric feeding lumen 670 distal to feed port 661. However, further distally no backfill is used, thus creating an open and usable guide tube or collection lumen 685.

Thus, it will be appreciated that during construction, a lumen extending through the entire length of the GJ tube device 660, but selectively inserted distally to the location of gastric feeding, can be formed, for example, by extrusion. A one-way valve, membrane, or the like discussed herein may be within the most distal portion of the collection lumen 685. As also discussed herein, a one-way valve or other obstruction can be recessed within the distal tip 687, as in FIG. 15.

An enlarged fixation portion 680, eg, a sleeve or simply an enlarged part of the GJ tube device 680, is positioned distally to the gastric feeding port 661 and distally to at least a portion of the backfill material 678. With this configuration, the user can cut the fixed portion 680 to create a new opening at the proximal end of the originally blind end of the collection lumen 685. Use of the GJ tube device 660 involves the user partially withdrawing the GJ tube device from the patient to expose the fixed portion 680, if used, then cutting the GJ tube device 660 and applying the clips. , is similar to other embodiments discussed herein in that the GJ tube apparatus 660 can then be exchanged for replacement.

Referring now to FIG. 21, there is a GJ tube apparatus 760 according to yet another embodiment. GJ tube device 760 has similarities to other embodiments discussed herein, but also has certain differences. GJ tube device 760 can be implemented similarly to GJ tube device 660 of FIG. A backfill 778 is included within a single tubular passage forming a collection lumen 785 with a backfill 778 . Cutting of the GJ tube device when the cut-resistant structure 795 is embedded within the GJ tube 760 and cut to form an opening in the collection lumen 785, similar to other embodiments discussed herein. works to prevent In some embodiments, cut-resistant structure 795 includes a metal wire or coil. In other examples, the cut-resistant structure 795 includes a relatively hard non-metallic material within the relatively soft non-metallic material that forms the suitable GJ tube device 760. Thus, although a user may be able to cut relatively soft non-metallic materials, the cutting will tend to be stopped by contact with the anti-cut structure 795. Because the GJ tube device 760 is not cut into two parts, the risk of the distal portion returning to the patient is reduced or eliminated, so the use of clips or similar structures or other techniques may not be necessary.

It is understood that while some of the aforementioned embodiments employ a single continuous passageway that is partially backfilled to divide the gastric feeding lumen from the collection lumen, the present disclosure is not limited in this regard. Should. The dedicated gastric feeding lumen may extend only as far as necessary to reach the gastric feeding port, for example running in parallel or sequentially to a blocked collection lumen at its proximal end. Those skilled in the art will envision yet other alternative strategies by which a user may access a normally closed collection lumen.

Industrial Applicability As mentioned above, medical professionals have long struggled with clogged GJ tubes that require replacement entirely when the clog cannot be cleared. 10-12 illustrate a procedure suitable for removing and replacing a GJ tube device according to one embodiment of the disclosed invention. In this particular example, a GJ tube device 270 according to one or more of the previously described embodiments having one or more clogged tubes/feeding lumens is replaced. The GJ tube device 270 in this example was first placed within the patient by making a stoma 278 through the abdominal wall 272 and stomach 274 such that the cut mark 280 on the tube was placed within the patient. In other instances, the cutting mark is outside the abdominal wall when the GJ tube device is placed correctly. If necessary, the balloon portion 276 of the inflated device is deflated to prevent unintentional withdrawal of the tube 270, and the GJ tube device 270 is withdrawn until the cut mark 280 is visible (FIG. 11).

As shown in FIG. 10, balloon portion 276 may include radiopaque stripes 290. As shown in FIG. The stripes or "stripes" 290 can stretch and potentially curve in response to inflation of the balloon portion 290, with the aid of radiography, with respect to the inflated versus uninflated state of the balloon portion 276. Provide visual instructions to the user. For example, stripes 290 may be parallel to each other when balloon portion 276 is uninflated. Such features can eliminate the need to use contrast agents to determine balloon status.

The exact distance that the GJ tube device is withdrawn from the patient's body to expose the cutting mark may vary, but may range from 5 cm to 20 cm in some cases. The distance that the GJ tube device is withdrawn from the abdominal wall and out of the patient will typically be less than the distance that the distal end of the GJ tube device is withdrawn past the pyloric valve/pylorus. The overall length of the GJ tube devices contemplated herein may be about 60 cm to about 75 cm, while the length between balloon portion 118 and the distal distal tip may be about 45 cm.

Once the cutting mark is exposed, the GJ tube device is cut along the mark with, for example, scissors or a surgical knife or scalpel to expose the interior of the device 282, including the opening 284 of the guide tube 286 that forms the rescue lumen. It may also be cut (FIG. 12). A guidewire 288 is then inserted through opening 284 and along the length of guide tube 286, thereby positioning guidewire 288 through the pyloric valve/pylorus and into the small intestine. The clogged GJ tube device may then be withdrawn from the patient over guidewire 288 and through stoma 278. The new GJ tube device is then inserted into the patient by passing it over the guidewire and advanced to the treatment location, with the gastrointestinal and jejunal feed ports of the new GJ tube positioned above and above the pylorus of the patient's gastrointestinal tract, respectively. located below. The guidewire is then withdrawn and the replacement GJ tube is secured using typical procedures.

18-19 illustrate a procedure suitable for removing and replacing a GJ tube device according to another embodiment of the disclosed invention. In this particular example, a GJ tube device 420 according to one or more of the previously described embodiments having one or more clogged tubes/feeding lumens is replaced. GJ tube device 420 includes a rescue tube 428 disposed therein having a sealed proximal end portion. A fixation portion 426, as previously described with respect to the embodiment shown in FIG. 14, surrounds a portion of the GJ tube device 420 near the sealed proximal end portion of the rescue tube 428. Fixed portion 426 may include marks or indicia indicating where it must be cut during the replacement procedure, or optionally, the device may be configured such that it can be cut anywhere on the fixed portion. .

In this example, GJ tube device 420 was initially placed through an ostium formed in abdominal wall 422 and stomach wall 424. Typically, such placement is performed using radiography, which may be assisted by fabricating all or a portion of the GJ tube device 420 from a radiopaque material. GJ tube device 420 is initially positioned such that the sealed end portion of rescue tube 428 is disposed within the abdomen, optionally within the stomach. In some examples, the rescue tube may be made of a generally less flexible material than the GJ tube device body. Thus, the portion of the GJ tube device that includes the rescue tube may be more rigid and placing them within the abdomen and/or stomach may be more difficult to secure than with a more flexible GJ tube. It may reduce irritation that may be caused by having a more rigid GJ tube placed outside the body.

The replacement process begins by releasing any securing features (tape, inflated balloon portion, etc.) and withdrawing GJ tube device 420 until at least a portion of securing portion 426 is exposed and accessible (see FIG. 19). shown). The exact distance that the GJ tube must be withdrawn may vary from application to application, but can be anywhere from about 5 cm to about 20 cm. The distance that the GJ tube device 420 is withdrawn from the abdominal wall is typically such as to reduce the risk of accidentally withdrawing the tube too far and requiring radiographic assistance to ensure proper placement of the new tube. , will be less than the distance to withdraw the distal end of the GJ tube device past the pyloric valve/pylorus. Once accessed, a fixation clip 432 is placed on the GJ tube device 420 distal to the fixation portion 426 to prevent the tube from returning to the abdominal wall. Once secured, the GJ tube device may be cut with scissors or a surgical knife or scalpel, for example. Cut line 430 may be made at any point along the body of GJ tube 420, including securing portion 426, such that the sealed distal end of rescue tube 428 is cut and removed, thereby removing the guide. The GJ tube apparatus is replaced, creating an exposure opening 436 into the rescue tube 428 into which a wire may be inserted. Optionally, the GJ tube device 420 includes cut line indicia 430, which may include colored marks, ridges or grooves formed in the tube body, or a combination thereof, to indicate a preferred cut zone or line.

This specification is for illustrative purposes and should not be construed in any way to narrow the scope of the disclosure. Accordingly, it will be apparent to those skilled in the art that various modifications may be made to the embodiments of the present disclosure without departing from the full and fair scope and spirit of the disclosure. Other aspects, features, and advantages will become apparent upon examination of the accompanying drawings and appended claims. As used herein, the articles "a" and "an" are intended to include one or more items and may be used interchangeably with "one or more." If only one item is intended, the term "an" or similar wording is used. Also, as used herein, terms such as "has,""have,""having," and the like are intended to be non-limiting terms. Further, the phrase "based on" is intended to mean "based at least in part on" unless expressly stated otherwise.

Claims (21)

a device body having an outer wall, a first proximal end, and a second distal end, the outer wall including an inflatable balloon portion;
a first tube having an opening in the proximal end of the device body and an opening in the inflatable balloon portion of the outer wall;
a second tube having an opening at the proximal end and an opening between the proximal end and the distal end;
a third tube having an opening at the proximal end and an opening at the distal end;
a guide tube having a closed proximal end and an opposite distal end disposed between the proximal end and the distal end of the device body;
cutting the device body creates an opening for the guide tube;
Gastrojejunal (GJ) tube device. the outer wall includes at least one cutting mark that includes a tactile feature and/or a color feature;
The GJ tube device according to claim 1. when the GJ tube device is placed, the distal end of the guide tube is positioned within the small intestine of the patient;
The GJ tube device according to claim 1. further comprising a one-way valve assembly at the distal end of the guide tube;
The GJ tube device according to claim 1. the length of the guide tube is 50% to 80% of the length of the GJ tube assembly;
The GJ tube device according to claim 1. the closed proximal end of the guide tube is disposed between at least one cutting mark of the GJ tube device and the proximal end;
The GJ tube device according to claim 1. the device body is formed from a first material;
the guide tube is formed from a second material different from the first material;
The GJ tube device according to claim 1. the second tube includes a gastric feeding tube;
the gastric feeding tube and the guide tube are separated by a backfill material;
The GJ tube device according to claim 1. The GJ tube device main body further includes a fixed portion having a larger diameter between the proximal end and the distal end.
The GJ tube device according to claim 1. the fixed portion includes at least one of a color feature, a texture feature, and a cut mark feature;
The GJ tube device according to claim 8. A method for replacing a GJ tube device according to claim 8, comprising:
engaging a clip with the GJ tube device distal to the fixed portion of the GJ tube device;
cutting the GJ tube device to create an opening in the guide tube;
inserting a guidewire through the opening of the guide tube until the guidewire exits the distal end of the guide tube;
withdrawing the GJ tube device while leaving the guidewire in place;
placing the new GJ tube device by threading the new GJ tube device over the guidewire;
Method. 1. A method of replacing a gastrojejunal (GJ) feeding tube device, the method comprising:
partially withdrawing the GJ feeding tube device from the patient to expose the cutting zone;
at least partially cutting the GJ feeding tube device to establish an opening to a collection lumen that extends to a distal end of the GJ feeding tube device within the patient;
advancing a guidewire through the collection lumen;
withdrawing the GJ feeding tube device from the patient while maintaining the guidewire within the patient;
A replacement GJ feeding tube device is placed over the guide wire such that the gastric feeding port of the GJ feeding tube device is placed above the pylorus of the patient and the jejunal feeding port of the GJ feeding tube device is placed below the pylorus. including proceeding;
Method. a device body having an outer wall, a first proximal end, and a second distal end; and an inflatable balloon portion;
a first tube defining an inflation fluid lumen extending between the proximal end of the device body and the inflatable balloon portion;
a second tube defining a gastric feeding lumen beginning at the proximal end of the device body and terminating in a gastric feeding port formed between the proximal and distal ends of the device body;
a third tube defining a jejunum supply lumen beginning at the proximal end of the device body and terminating in a jejunum supply port formed at the distal end of the device body;
a GJ tube device having a guide tube defining a collection lumen that begins at a closed end and extends to a distal end disposed at a location distal to the gastric feeding port;
at least one securing clip;
Gastrojejunal (GJ) tube replacement kit. The length of the guide tube is 50% to 80% of the length of the GJ tube device main body,
The kit according to claim 13. 14. The kit of claim 13, wherein the GJ tube includes an enlarged fixed portion. the enlarged fixed portion of the GJ tube includes at least one of a color feature, a texture feature, and a cut mark feature;
The kit according to claim 15. The GJ tube device further includes a one-way valve assembly positioned at the distal end of the guide tube.
The kit according to claim 13. the one-way valve assembly recessed proximally from the distal tip of the GJ tube device;
Kit according to claim 17. a device body having an outer wall, a first proximal end, and a second distal end;
a first tube of the device body forming a lumen having a first opening at the proximal end of the device body and a second opening at the distal end of the device body;
the device body forming a lumen having an open first end at the device body proximal end and a closed second end disposed between the device body proximal end and the device body distal end; a second tube of the device body;
forming a lumen having a closed first end disposed between the proximal end of the device body and the distal end of the device body and a second end opposite the distal end of the device body; a third tube of the device main body;
medical equipment. the closed second end of the second tube is an inflatable balloon portion;
a fourth tube of the device body forming a lumen having an open first end at the proximal end of the device body;
further comprising a plurality of supply ports disposed between the proximal end of the device main body and the closed first end of the third tube;
20. Medical device according to claim 19. further comprising a cut-resistant structure positioned between the device body proximal end and the device body distal end to limit cutting of the device body;
20. Medical device according to claim 19.

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